1. Field of the Invention
The present invention generally relates to improved methods, devices and system for disease management. More particularly, the present invention relates to real-time communication of data between devices (e.g., blood glucose meters, insulin delivery devices) and a repository and analysis of repository data to obtain information to improve disease management and provide cost savings to disease management stakeholders.
2. Description of the Related Art
FIG. 1 illustrates an existing system 10 for diabetes management. For convenience, the following abbreviations shall be used herein:
BGM blood glucose meter
DM diabetes management
DMC disease management companies
DMD diabetes management data
WM wireless BGM
As shown in FIG. 1, a patient 12 performs blood glucose monitoring (e.g., using lancets and a BGM 18 with test strips, or a continuous meter) and administers insulin injections (e.g., via a syringe, pen or pump 20) as needed. The BGM and the insulin injections are typically recorded manually in a notebook 22 by the patient or his or her caregiver to share with a healthcare provider such as a doctor 14 or a disease management company 16. This information is typically shared via telephone (e.g., telephone 26, 28 and 32), computer (e.g., computers 24 and 30), or in person during office visits. This information can also include information relating to diet, exercise and other factors that influence diabetes management outcomes. Unfortunately, this information is not verified and often not recorded, collected or managed in a reliable and cohesive manner to be useful to the patient's healthcare team in facilitating optimal diabetes management.
With continued reference to FIG. 1, diabetes management data such as blood glucose tests and insulin intake can be recorded using a personal computer (PC) 24, as opposed to handwritten record keeping 22, or uploaded to a patient's PC 24 from a device (e.g., a blood glucose meter 18 or insulin delivery pen 20) using a software interface. Conventional communications interfaces, however, are inconvenient because a patient 12 must acquire a communication interface such as a specialized modem and/or install software on a PC 24 to upload data from a BGM 18. Further, such PC interfaces for diabetes data management do not necessarily allow the entered data to be shared with other stakeholders in diabetes management and care, that is, physicians and other healthcare providers 14, insurers, or disease management companies (DMCs) 16 that are typically hired by employers or insurance companies, as indicated by the optional lines shown in phantom in FIG. 1. If diabetes management data from a patient 14 can be provided to a healthcare team member's PC 30, that information is generally not recorded in a comprehensive manner that assures completeness, accuracy and timeliness of the data. For example, quite often patients 14 fail to test, or to write down, enter or upload a blood glucose test result or insulin injection, leaving healthcare team members 30 and 16 with incomplete information and not allowing them to identify teachable moments or events in diabetes management or respond in real-time.
Similarly, special cradles such as GlucoMON by Diabetech in Dallas, Tex., are currently available to get data from a patient 14 securely to other people. Diabetech makes the device and manages the service to transmit blood glucose test results to selected people, typically via cell phone, pager, or e-mail, according to the instructions of the patient 14 or their legal guardian. This data, however, is merely reported to selected persons and not collected and managed in a comprehensive manner. Additionally, this system requires that the user 14 acquire and connect a secondary device to their BGM 18. Thus, a need exists for an integrated device for monitoring glucose levels and reporting same to other stakeholders in diabetes management and care.
Cell phones combined with diabetes data management functions have been proposed, not surprisingly in an era of increasingly indispensable personal electronic devices. For those with chronic conditions such as diabetes, technical convergence of healthcare and personal electronic technology makes even more sense to facilitate use of medications, meters, pumps, injections, and the need to carefully track and document important health data, particularly for those with chronic conditions that require significant self-management.
Several medical companies are developing smarter, more convenient monitoring equipment and are using telecommunications technology to create multipurpose, portable devices for patient use. One of these companies is HealthPia America, a Newark, N.J.-based telemedicine venture that has developed a cell phone that also serves as a blood glucose monitor and features a pedometer. An embedded electronic biosensor in the battery pack enables the cell phone to have a glucose meter function. The sensor reads blood glucose levels from a strip. The data is then uploaded to the cell phone's display. The phone can be programmed to send the information instantly to a health care provider 14, parent, or guardian. Movement and exercise also can be monitored with the built-in pedometer. The phone can be programmed to send an alert to the caregiver or clinician via short-message service if there is no pedometer reading for a pre-programmed length of time. The care manager can call back to check if the patient 12 is okay, and if there is no response, prearranged emergency procedures can be initiated. This feature could be especially useful for detecting insulin reactions or severe hypoglycemia in diabetes patients 12. The biggest advantage of the Diabetes Phone is its alarm features, which allow a physician to set specific parameters. If the phone reports continuously high blood glucose, for example, a doctor can react in real-time.
Other diabetes cell-phone projects include research at Oxford University in the U.K. to test a system similar to that of HealthPia America. In another venture, British patients 12 with diabetes have been able to register since 2002 with Sweet Talk, a message service that reminds them via cell phone to take their insulin and offers general education about living with diabetes. Further, in 2003, IBM announced that its “Bluetooth” short-range wireless technology could be used to intercept a person's 12 heart rate and send it to a cell phone.
At the ITU Telecom Asia 2004 show in Korea, LG Electronics showed a novel handset, the KP8400. The KP8400 is designed for diabetics and is capable of doing blood sugar level tests just as would a dedicated device. Users 12 place a strip of testing paper into the sensor located in the phone's battery pack, place a drop of blood on the end of the strip, and then get a reading from the phone. The reading can then be uploaded to an online database for later retrieval. LG Electronics has a strategic alliance with Healthpia Co., Ltd. to implement the KP8400.
Whether these new and proposed electronic devices for diabetes management will result in their widespread adoption and better self-care for patients 12, or simply more work for clinicians 14 as they strive to manage a new stream of information, is the central question as this new frontier of electronic medicine is explored. For example, the data reported by one of these emerging cell phone technologies does not appear to be managed in a cohesive manner such that the real-time test results can be associated with other information such as test trip lot number and use verification, or mealtime events and therapy intervention (e.g., insulin injection), and the like.
Further, what is largely overlooked is the value to less traditional stakeholders in the business of DM. A need therefore exists for business models, methods and apparatuses that maximize the value of collected DMD for various stakeholders such as disease management companies 16, insurers and healthcare networks.
As stated above, disease management companies 16 are typically hired by a patient's insurer or employer to provide the patient 12 with educational support for their disease. DMCs obtain claims data such as prescriptions and visits to healthcare providers 14, as well as other data such as BG measurements, insulin dosages, diet and exercise. Much of this information is collected from the patient 12 via telephone (e.g., telephones 26, 28 and 32) which is problematic for a number of reasons. For whatever reasons, patients are often not completely truthful with their healthcare providers 14 and DMC 16 representative about their DM lifestyle choices (e.g., diet, exercise, BG testing and medicating with insulin). Some of the reasons are inadequate education about diabetes self-management, apathy, embarrassment, economic barriers, lack of proficiency in testing and use of data interface equipment, or faulty equipment or testing technique (e.g., poor timing with respect to meal times).
A need therefore exists for a diabetes data management system that allows DMCs 16 and other third parties (e.g., insurance companies, Medicare, Medicaid, HMOs, etc.) to provide patients 12 with incentives to take better care of themselves and manage their diabetes and otherwise improve their outcomes. For example, a need exists for a system that can monitor and have verification of a patient's actual blood glucose monitoring practices. A DMC 16 can then, for example, remove economic barriers by giving patients, who have shown progress in managing their diabetes, test strips and/or a blood glucose monitor at nominal cost or no charge or by waiving their co-pays.
Currently, reimbursement for diabetes testing supplies by third parties (e.g., insurance companies, Medicare, Medicaid, HMOs, etc.) is based on a model where a specific number of BGM test strips are covered depending on the patient's condition (e.g., a person 12 with diabetes who requires insulin injections to help manage their diabetes may have coverage for 60 BGM test strips per month (2 per day); or a person 12 with diabetes who uses an oral medication to help manage their diabetes may have coverage for 30 BGM test strips per month (1 per day).) In this model, the refill of a BGM test strip prescription is the only indication of use of the BGM test strips. However, this does not provide any objective evidence: a) that the patient 12 actually tested their blood glucose using the BGM test strips; b) that the tests were done at appropriate times; c) of the results of any tests that were done. In some situations, patients 12 may “stockpile” their test strips or provide them to other family members or friends who do not have equivalent insurance coverage for their needs. In these cases, the third party payor is making payments for testing supplies that are not being used or not being used appropriately. In this model, for example, the mail order supplies company and, ultimately, the BGM test strip manufacturer benefit because they are paid by the third parties for all test strips that are delivered to the patient regardless of the patient's actual use. A need therefore exists for a “pay for results” model wherein a payor pays for only those strips that are actually used.